Insys Therapeutics Inc (NASDAQ:INSY) has extended the compassionate use trials of its proprietary oral formulation of Hemp for the cure of refractory pediatric epilepsy, allowing patients from previous clinical studies of the investigational drug to continue getting it as per the protocols originally approved by the U.S. FDA and under the guidance of their physicians.

The details

The original 48-week extended access program after a long-term safety trial that permitted patients who had concluded the initial 10-day pharmacokinetics and safety trial to continue getting the firm’s Hemp oral solution at doses up to 40 mg per kg per day for up to 48 weeks. In the preliminary PK and safety study, 61 subjects with refractory epilepsy between the ages group of 1 and 17 years were given total daily doses of 10 mg per kg, 20 mg per kg or 40 mg per kg. Of these 61 subjects, 52 continued into the long-term safety trial, of which 45 have concluded 48 weeks of treatment across numerous investigative sites in the U.S.

Expanded access offers a pathway for subjects to gain access to investigational drugs before they are permitted by the FDA. Around 31 of the 45 subjects in the long-term safety trial of Insys Hemp oral solution targeting refractory pediatric epilepsy have registered in the expanded access plan, including 12 under the supervision of Dr. Steven Phillips, M.D. Dr. Phillips, a key investigator in the expanded access trials, all 12 of their families are grateful that they continue to get Cannabidiol for their kids through the expanded access plan for Hemp from Insys.

Seizure control has continued to be improved on Hemp as against to when not on Cannabidiol, and this effect has been kept for numerous years. As importantly, they have noted minimal side effects with Cannabidiol and an overall improvement in the life quality of patients.

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